Automation in manufacturing facilities is becoming increasingly more popular. Typically, numerous devices or equipment for performing different functions are involved to produce a product. These devices can be supplied by various equipment manufacturers, each utilizing a proprietary protocol of its respective equipment manufacturer. The different proprietary protocols require customization (e.g., software) for automation. Production of the product begins once the production line is validated.
One problem with conventional automation systems is their inflexibility and inefficiency in adapting over time to arising or changing needs. For example, changes in automated devices, either manufacturer or model, will often require a complete automation software revision, reconfiguration and re-validation of the entire system. This is both costly and time consuming. As a result, manufacturers are reluctant to make any type of changes in the production line (e.g., replacement, removal or addition of equipment, upgrading, relocating, or expansion). The inflexibility of conventional automated systems also impedes the adoption of new technology in certain highly regulated industry such as the application of Process Analytical Technology (PAT) to be introduced to the pharmaceutical industry.
Good change controls for the replacement of the equipment from one type to another are integral in quality assurance of production facilities, especially in highly regulated industries such as life sciences, pharmaceuticals, food and beverage or healthcare. Ideally, the design of the automation system should facilitate and improve the efficiency of the change process.
Many regulatory agencies, such as the United States Food and Drug Administration (FDA), require that the drug product be tested for identity, strength, quality, purity and stability before it can be released for use. For this reason, validation should be considered whenever changes are introduced to the process or equipment. When any new equipment is adopted, steps should be taken to demonstrate its suitability for routine processing and to provide a high degree of assurance that all parts of the facility will consistently work correctly when brought into use. The defined process, using the materials and equipment specified, should be shown through, for example, documented evidence to consistently yield a product of the required quality.
However, as already discussed, conventional automation systems are not conducive to changes due to its inflexibility. Such system inflexibility requires extensive recustomization and revalidation of the entire production line when changes are desired, incurring delays as well as costs.
From the foregoing discussion, it is desirable to provide an automation system which is efficient, robust and highly adaptable to changes in order to cope with changing requirements in manufacturing to meet market demands as well as complying with regulatory standards.